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Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic

Choroideremia

REP1 Gene Replacement Therapy for Choroideremia 212.26 Ko 24/07/2020
STAR 233.50 Ko 12/11/2018
A Multicenter Prospective Observational « Natural History » Study in Patients With Choroideremia 201.42 Ko 16/07/2020
Gemini 203.60 Ko 16/07/2020
A Randomised, Open Label, Outcomes-Assessor Masked, Prospective, Parallel Controlled Group, Phase 3 Clinical Trial Of Retinal Gene Therapy For Choroideremia Using An Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1) 216.10 Ko 16/07/2020
SOLSTICE 209.87 Ko 16/05/2019
Night 216.60 Ko 16/07/2020
CIL 34546-NSR-REP-01 212.57 Ko 16/05/2019
THOR (Choroideremia (phenotype + approved molecular diagnosis)) 221.28 Ko 21/06/2018

Retinitis Pigmentosa

XIRIUS (X-linked RP) 211.63 Ko 16/05/2019
Rate of Progression in USH2A Related Retinal Degeneration (RUSH2A) (Retinitis pigmentosa, Usher Syndrome) 231.16 Ko 16/05/2019
Clinical implication of Retinitis Pigmentosa molecular diagnostic using high throughput sequencing (RP-SEQ-HD) 227.18 Ko 13/06/2018
Therapeutic management of patients with cystoid macular edema secondary (retinitis pigmentosa) 252.80 Ko 16/05/2018
Argus® II Retinal Stimulation System Feasibility Protocol (retinotosis pigmentosa) 2 212.46 Ko 09/07/2020
Argus® II Retinal Prosthesis System: Post-Market Study 200.83 Ko 10/07/2020
Study of the Efficacy and Safety of QLT091001 in Subjects with Inherited Retinal Disease (IRD) Caused by Mutation in Retinal Pigment Epithelium Protein 65 (RPE65) or Lecithin:Retinol Acyltransferase (LRAT) (Retinitis pigmentosa; Inherited Retinal Disease 222.87 Ko 16/05/2018
Retinitis pigmentosa: molecular diagnosis by next generation sequencing (inherited retinal dystrophy) 251.00 Ko 16/05/2018
Study of UshStat in Patients With Retinitis Pigmentosa Associated With Usher Syndrome Type 1B (Retinitis Pigmentosa Associated With Usher Syndrome Type 1B) 201.27 Ko 10/07/2020
Natural History Study in Inherited Retinal Disease Subjects Caused by Mutations in RPE65 or LRAT 215.14 Ko 17/09/2020
Oral QLT091001 in Retinitis Pigmentosa (RP) Subjects With an Autosomal Dominant Mutation in Retinal Pigment Epithelial 65 Protein (RPE65) 201.73 Ko 09/07/2020
Clinical Characterization on PDE6A-related Retinitis Pigmentosa in Preparation to a Gene Therapy Trial 201.03 Ko 16/07/2020
PIGMENT – PDE6A gene therapy for retinitis pigmentosa 200.91 Ko 20/07/2020
TES for the Treatment of Retinitis Pigmentosa (RP) 209.43 Ko 20/07/2020
Rate of Progression in EYS Related Retinal Degeneration (Pro-EYS) 214.02 Ko 29/06/2020
Natural history of the progression of X-linked retinitis pigmentosa 514.39 Ko 09/07/2020
Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa 199.06 Ko 16/07/2020
Transcorneal Electrical Stimulation - Multicenter Safety Study 202.87 Ko 16/07/2020
Safety and Efficacy of the Alpha AMS Subretinal Implant 199.51 Ko 24/07/2020
Safety and Efficacy of a Unilateral Subretinal Administration of HORA-PDE6B in Patients With Retinitis Pigmentosa Harbouring Mutations in the PDE6B Gene Leading to a Defect in PDE6ß Expression 208.42 Ko 16/05/2019
Repeated Treatments of QLT091001 in Subjects With Leber Congenital Amaurosis or Retinitis Pigmentosa (Extension of Study RET IRD 01) 214.50 Ko 17/09/2020
VITAL (USHER syndrome induced by MYO7A mutation and retinotosis pigmentosa) 239.78 Ko 05/07/2018
Retrospective Natural History Study of Retinitis Pigmentosa Rare Eye 198.92 Ko 16/07/2020
Prospective Natural History Study of Retinitis Pigmentosa (PHENOROD2 214.81 Ko 29/06/2020
Autosomal Dominant Retinitis Pigmentosa: Prevalence of Known Genes Identification of New Loci / Genes 212.88 Ko 10/07/2020
Validation of standardized test protocols to assess the impact of visual pathologies in daily life activities 212.48 Ko 29/06/2020
A Post-Authorization, Multicenter, Multinational, Longitudinal,Observational Safety Registry Study for Patients Treated withVoretigene Neparvovec 199.94 Ko 29/06/2020
Design of a mobility protocol allowing to assess the impact of visual pathologies in activities of daily living for subjects with advanced visual deficits 221.12 Ko 29/06/2020
Safety and Efficacy of Subretinal Implants for Partial Restoration of Visionin Blind Patients 206.70 Ko 16/07/2020
Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors 205.83 Ko 16/07/2020
A Dose Ranging Study to Evaluate the Safety and Potential Efficacy of rhNGF in Patients With Retinitis Pigmentosa (RP) 208.35 Ko 20/07/2020
Interventional Study of Implantation of hESC-derived RPE in Patients With RP Due to Monogenic Mutation 201.22 Ko 16/07/2020
Dose-escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa (PIONEER) 213.42 Ko 23/05/2019
Study to Evaluate Safety and Tolerability of QR-421a in Subjects With Retinitis Pigmentosa Due to Mutations in Exon 13 of the USH2A Gene (Stellar) 211.63 Ko 23/05/2019
Visual and Functional Assessment in Low Vision Patients 209.54 Ko 24/07/2020

Leber Hereditary Optic Neuropathy (LHON)

Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey 201.15 Ko 10/07/2020
Trial of Cyclosporine in the Acute Phase of Leber Hereditary Optic Neuropathy 199.37 Ko 10/07/2020
Historical Case Record Survey of Visual Acuity Data From Patients With Leber’s Hereditary Optic Neuropathy (LHON) 2 229.60 Ko 16/07/2020
A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Clinical Trial With KH176 200.82 Ko 09/07/2020
Observational Registry Study of Leber Hereditary Optic Neuropathy (LHON) Affected Patients 212.60 Ko 23/05/2019
Non-interventional Study of Clinical Experience in Patients Prescribed Raxone® for the Treatment of Leber's Hereditary Optic Neuropathy (LHON) (Leber's Hereditary Optic Neuropathy) 224.43 Ko 16/05/2018
REVERSE 212.38 Ko 16/05/2019
Efficacy & Safety Study of Bilateral Intravitreal Injection of GS010 in LHON Subjects Due to the ND4 Mutation for up to 1 Year (REFLECT) 213.62 Ko 23/05/2019
An open label dose escalation clinical trial to evaluate the safety and the tolerability of gs010 (rAAV2/2-ND4) in patients with leber hereditary optic neuropathy due to mutations in the mitochondrial nadh dehydrogenase 4 gene 201.31 Ko 10/07/2020
Efficacy & Safety Study of Bilateral Intravitreal Injection of GS010 in LHON Subjects Due to the ND4 Mutation for up to 1 Year (REFLECT) 204.57 Ko 10/07/2020
Efficacy Study of GS010 for the Treatment of Vision Loss up to 6 Months From Onset in LHON Due to the ND4 Mutation 202.35 Ko 02/09/2020
RESCUE AND REVERSE 210.93 Ko 02/09/2020

Leber Congenital Amaurosis

Natural History Study in Inherited Retinal Disease Subjects Caused by Mutations in RPE65 or LRAT 215.14 Ko 09/07/2020
Clinical Gene Therapy Protocol for the Treatment of Retinal Dystrophy Caused by Defects in RPE65 199.83 Ko 10/07/2020
Repeated Treatments of QLT091001 in Subjects With Leber Congenital Amaurosis or Retinitis Pigmentosa (Extension of Study RET IRD 01) 214.50 Ko 09/07/2020
Safety Study of RPE65 Gene Therapy to Treat Leber Congenital Amaurosis 206.96 Ko 20/07/2020
Genetic Decryption of Leber Congenital Amaurosis (LCA) in a Large Cohort of Independent Families 199.56 Ko 10/07/2020
Extension Study to Study PQ-110-001 (NCT03140969) 200.98 Ko 16/07/2020
Efficacy and safety of QLT091001 in subjects with Inherited Retinal Disease (IRD) caused by gene mutations 233.93 Ko 16/05/2019
RET-IRD-04 233.93 Ko 16/05/2018
Genetic Study of Patients Suffering From Congenital Amaurosis of Leber or From an Early Severe Retinal Dystrophy 200.64 Ko 17/09/2020
A double-masked, randomized, controlled, multiple-dose study to evaluate theefficacy, safety, tolerability and systemic exposure of QR-110 in Subjects withLeber’s Congenital Amaurosis (LCA) due to c.2991+1655A>G mutation (p.Cys998X) in the CEP290 gene (Il 218.39 Ko 09/07/2020
Study to Evaluate QR-110 in Subjects With Leber’s Congenital Amaurosis (LCA) Due to the c.2991+1655A>G Mutation (p.Cys998X) in the CEP290 Gene 201.73 Ko 09/07/2020
Genetic Study of Patients Suffering From Congenital Amaurosis of Leber or From an Early Severe Retinal Dystrophy 200.64 Ko 24/07/2020

Stargardt Disease

Hereditary retinal disease

Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS 199.88 Ko 16/07/2020
Cornea Ectasia Excimer Laser Treatment 196.56 Ko 20/07/2020
CURETINA personalized medicine in hereditary retinal degenerations 209.77 Ko 16/07/2020
Clinical and Molecular Studies in Families With Inherited Eye Disease 197.07 Ko 20/07/2020
ReCOVER (This trial does use Clemastine fumarat as a remyelinating agent targeting the muscarinic receptor on oligodendrocytes around the optic nerve) 210.55 Ko 16/05/2019
Prospective Analysis of «Genotype-phenotype» Correlations Observed in a Large Cohort of Patients With Hereditary Retinal Dystrophies - GEPHIRD 210.42 Ko 09/07/2020
Phase I Trial of Gene Vector to Patients with Retinal Disease due to RPE65 mutations 199.70 Ko 09/07/2020
Argus II retinal prosthesis system post- market surveillance study protocol (inherited retinal dystrophy & choroidal dystrophy) - Copie 260.69 Ko 24/07/2020
Nanometer-controlled cut-off filters in real-life self-reported quality of vision of patients with retinitis pigmentosa (inherited retinal dystrophy) 251.76 Ko 16/05/2018

Neurotrophic Keratitis

Evaluation of safety and efficacy of r-hNGF (Neurotrophic Keratitis) 211.29 Ko 28/11/2018

CNGA3-linked achromatopsia

CNGA3 (CNGA3-linked achromatopsia) 2 228.44 Ko 16/05/2019
Safety and efficacy of a single subretinal injection of rAAV.hCNGA3 in patients with CNGA3-linked achromatopsia investigated in an exploratory, dose-escalation trial 223.28 Ko 16/07/2020

Argus II

Argus® II Retinal Stimulation System Feasibility Protocol (retinotosis pigmentosa) 2 - Copie 212.46 Ko 24/07/2020
Argus® II Retinal Prosthesis System: Post-Market Study - Copie 200.83 Ko 24/07/2020
Self-confidence Study in Patients With Argus II Artificial Retina Rare Eye 198.42 Ko 10/07/2020
Argus II retinal prosthesis system post- market surveillance study protocol (inherited retinal dystrophy & choroidal dystrophy) 260.69 Ko 24/07/2020

Glaucoma

Long-Term Non-Interventional Latanoprost Study 270.68 Ko 05/07/2018

Usher Syndrome

Light4deaf study: study of the natural history of the syndrome of usher in a cohort of patients followed longitudinally for 5 years (Usher Syndrome) 224.37 Ko 16/05/2018
Rush2A 249.81 Ko 08/11/2018
Natural History Study in Subjects With Usher Syndrome 2 195.96 Ko 20/07/2020
Clinical and Genetic Examination of Usher Syndrome Patients’ Cohort in Europe 200.22 Ko 10/07/2020
Open-Label Study to Determine the Long-Term Safety, Tolerability and Biological Activity of UshStat® in Patients With Usher Syndrome Type 1B (Usher Syndrome) 225.23 Ko 16/05/2018
VITAL (USHER syndrome induced by MYO7A mutation and retinotosis pigmentosa) - Copie 239.78 Ko 24/07/2020
Study to Evaluate Safety and Tolerability of QR-421a in Subjects With Retinitis Pigmentosa Due to Mutations in Exon 13 of the USH2A Gene (Stellar) - Copie 211.63 Ko 24/07/2020

Bardet-Biedl

Bardet-Biedl Syndrome Study: Clinical and Genetic Epidemiology Study in Adults 201.36 Ko 10/07/2020
Treatment of Bardet-Biedl-Syndrome With Metformin for Evaluation of a Possible Visual Improvement 202.18 Ko 16/07/2020
Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Patients With Moderate to Severe Obesity 204.17 Ko 29/06/2020

Alström Syndrome

Clinical Study of a single ciliopathy: Alström Syndrome 2 210.92 Ko 10/07/2020
Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Patients With Moderate to Severe Obesity 204.17 Ko 24/07/2020

Chorioretinopathy

SPECTRA trial (central serous chorioretinopathy) 2 207.19 Ko 20/07/2020

Keratoconus

Measurement of High Order Aberrations in Late Stages Keratoconus 199.80 Ko 16/07/2020
Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients 196.90 Ko 20/07/2020
Transepithelial Corneal Collagen Crosslinking in Eyes With Progressive Keratoconus 199.47 Ko 16/07/2020
Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up. 197.63 Ko 20/07/2020

Congenital cataract registry

Longitudinal observation of factors affecting sight development in congenital cataract patients, long term observation of IOL implantation outcomes 226.24 Ko 10/07/2020

Ichthyosis

Prevalence of Ophthalmological Abnormalities in Children and Adults suffering from Hereditary Ichthyosis 201.20 Ko 02/07/2020

Trisomy 21

Trisomy 21 in Adulthood : a medical and social situation in Alsace 227.20 Ko 13/06/2018

Other

High resolution and high speed Multimodal Ophthalmic Imaging (IMA-MODE) 200.21 Ko 29/06/2020
High Resolution Retina Imaging (IHR) Rare Eye 198.46 Ko 29/06/2020
A Study to Determine the Safety and Efficacy of RenexusÂ® in Macular Telangiectasia Type 2 202.20 Ko 16/07/2020
Advanced Characterization of Autosomal Dominant Optic Atrophy 200.96 Ko 09/07/2020
Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease 202.89 Ko 16/07/2020
EPI-743 in Cobalamin C Defect: Effects on Visual and Neurological Impairment 199.09 Ko 20/07/2020

Choroideremia

Hereditary retinal disease

Retinitis Pigmentosa

Stargardt Disease

Leber Hereditary Optic Neuropathy (LHON)

Chorioretinopathy

Leber Congenital Amaurosis

Congenital cataract registry

Neurotrophic Keratitis

CNGA3-linked achromatopsia

Argus II

Glaucoma

Usher Syndrome

Bardet-Biedl

Alström Syndrome

Ichthyosis

Keratoconus

Trisomy 21

Other

Search for a Clinical trial:

Choroideremia

REGENERATE - NCT02407678

REP1 Gene Replacement Therapy for Choroideremia

Choroideremia

NCT02671539

THOR

Choroideremia

NCT03496012

STAR

Choroideremia

NCT01461213

CIL 34546-NSR-REP-01

Choroideremia

NCT03507686

Gemini

Choroideremia

NCT03584165

SOLSTICE

Choroideremia

NCT03359551

Night

Choroideremia

NCT02994368

A Multicenter Prospective Observational « Natural History » Study in Patients With Choroideremia

Choroideremia

Hereditary retinal disease

RSFVEN-330/2010-TRIS

Nanometer-controlled cut-off filters in real-life self-reported quality of vision of patients with retinitis pigmentosa

Hereditary retinal disease

NCT00481546

LCA

Hereditary retinal disease

NCT03662386

GEPHIRD

Hereditary retinal disease

NCT02771236

Clinical and Molecular Studies in Families With Inherited Eye Disease

Hereditary retinal disease

NCT01490827

Argus II retinal prosthesis system post-market surveillance study protocol (Argus II PM-01-01)

Hereditary retinal disease

RECOVER

Hereditary retinal disease

CURETINA

Hereditary retinal disease

NCT04405882

Cornea Ectasia Excimer Laser Treatment

Hereditary retinal disease

NCT03561922

Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS

Hereditary retinal disease

Retinitis Pigmentosa

NCT03146078

RUSH2A

Retinitis Pigmentosa

NCT00407602

Argus® II Retinal Stimulation System Feasibility Protocol

Retinitis Pigmentosa

NCT03780257

STELLAR

Retinitis Pigmentosa

NCT02759952

Clinical Characterization on PDE6A-related Retinitis Pigmentosa in Preparation to a Gene Therapy Trial

Retinitis Pigmentosa

NCT01876147

Visual and Functional Assessment in Low Vision Patients

Retinitis Pigmentosa

PROST

Validation of standardized test protocols to assess the impact of visual pathologies in daily life activities

Retinitis Pigmentosa

NCT03326336

PIONEER

Retinitis Pigmentosa

NCT02110225

LUMOS

Retinitis Pigmentosa

NCT03314207

XOLARIS

Retinitis Pigmentosa

PROMA

Design of a mobility protocol allowing to assess the impact of visual pathologies in activities of daily living for subjects with advanced visual deficits

Retinitis Pigmentosa

NCT02575430

Natural History Study in Inherited Retinal Disease Subjects Caused by Mutations in RPE65 or LRAT

Retinitis Pigmentosa

NCT04285398

PHENOROD2

Retinitis Pigmentosa

NCT03975543

PHENOROD1

Retinitis Pigmentosa

VITAL

Retinitis Pigmentosa

NCT02303288

Argus® II Retinal Prosthesis System: Post-Market Study

Retinitis Pigmentosa

NCT01835002

TESOLA

Retinitis Pigmentosa

NCT01024803

Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients

Retinitis Pigmentosa

PASS

A Post-Authorization, Multicenter, Multinational, Longitudinal,Observational Safety Registry Study for Patients Treated with Voretigene Neparvovec

Retinitis Pigmentosa

NCT03116113

XIRIUS

Retinitis Pigmentosa

NCT01505062

Study of UshStat in Patients With Retinitis Pigmentosa Associated With Usher Syndrome Type 1B

Retinitis Pigmentosa

NCT03963154

STREAM

Retinitis Pigmentosa

NCT03328130

Safety and Efficacy of a Unilateral Subretinal Administration of HORA-PDE6B in Patients With Retinitis Pigmentosa Harbouring Mutations in the PDE6B Gene Leading to a Defect in PDE6B Expression

Retinitis Pigmentosa

NCT00515814

Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors

Retinitis Pigmentosa

NCT02860520

Clinical implication of Retinitis Pigmentosa molecular diagnostic using high throughput sequencing (RP-SEQ-HD)

Retinitis Pigmentosa

NCT01235624

Autosomal Dominant Retinitis Pigmentosa: Prevalence of Known Genes Identification of New Loci / Genes

Retinitis Pigmentosa

RSFVEN-330/2010-BIS

Therapeutic management of patients with cystoid macular edema secondary to retinitis pigmentosa

Retinitis Pigmentosa

DIIO_EPPR_P13_03

Retinitis pigmentosa: molecular diagnosis by next generation sequencing

Retinitis Pigmentosa

NCT01521793

RET IRD 02

Retinitis Pigmentosa

NCT02720640

Safety and Efficacy of the Alpha AMS Subretinal Implant

Retinitis Pigmentosa

EST_2 - NCT01837901

Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa

Retinitis Pigmentosa

Pro-EYS - NCT04127006

Rate of Progression in EYS Related Retinal Degeneration (Pro-EYS)

Retinitis Pigmentosa

TESOLAUK - NCT01847365

TES for the Treatment of Retinitis Pigmentosa (RP)

Retinitis Pigmentosa

EudraCT 2016-003705-34

PIGMENT – PDE6A gene therapy for retinitis pigmentosa

Retinitis Pigmentosa

RET RP 01 - NCT01543906

Oral QLT091001 in Retinitis Pigmentosa (RP) Subjects With an Autosomal Dominant Mutation in Retinal Pigment Epithelial 65 Protein (RPE65)

Retinitis Pigmentosa

NCT01496040

Clinical Gene Therapy Protocol for the Treatment of Retinal Dystrophy Caused by Defects in RPE65

Retinitis Pigmentosa

2013-005393-22

A Study of the Efficacy and Safety of QLT091001 in Subjects with Inherited Retinal Disease (IRD) Caused by Mutation in Retinal Pigment Epithelium Protein 65 (RPE65) or Lecithin : Retinol Acyltransferase (LRAT)

Retinitis Pigmentosa

Stargardt Disease

NCT01736592

A Study to Determine the Long Term Safety, Tolerability and Biological Activity of SAR422459 in Patients With Stargardt’s Macular Degeneration

Stargardt Disease

NCT03297515

MADEOS

Stargardt Disease

NCT02410122

PROGSTAR-4 STUDY

Stargardt Disease

NCT01367444

Phase I/IIa Study of SAR422459 in Patients With Stargardt’s Macular Degeneration

Stargardt Disease

NCT03772665

SeaSTAR

Stargardt Disease

NCT02771379

PAROS

Stargardt Disease

NCT01469832

Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (hESC-RPE) Cells in Patients With Stargardt’s Macular Dystrophy (SMD)

Stargardt Disease